CMS releases overdue Sunshine Act guidance
Two months past deadline, the Centers for Medicare & Medicaid Services has released a proposed rule offering guidelines for how drug and device makers will report their contracts with physicians.
CMS' guidelines were originally supposed to be released last October but weren't. At the time, then-CMS administrator, Donald Berwick, said the delay was due to the agency working on a presidential directive for all federal agencies to come up with plans to reduce regulatory burden.
The lack of direction from CMS was frustrating to those who were expected to comply with the Physician Payments Sunshine Act, the Affordable Care Act regulation that requires drug, device and biological companies, medical supply manufacturers and group purchasing organizations to publicly disclose their financial relationships with doctors and teaching hospitals, said Animesh Gandhi, director of aggregate spend at Alliance Life Sciences.
"From a company point of view (the lack of guidance from CMS was) a bit of a mess," said Gandhi. Drug and device companies expected to have to begin to start collecting data to report to the government beginning on Jan. 1, 2012, and were to begin submitting that data by the end of March 2013. Without CMS' guidance, companies were struggling to determine how and what to report by those deadlines, Gandhi said.
CMS' proposed rule, released Wednesday, has eliminated the original deadlines. The agency said it is considering requiring the collection of data for part of 2012 and having that data reported to CMS by March 31, 2013, but it doesn't plan on requiring the collection of data until the final rule is issued.
"The completion of the guidance is good news," said Sen. Charles Grassley (R-Iowa), in a statement. Grassley and Sen. Herb Kohl (D-Wis.) developed the Sunshine Act and have been pushing CMS to issue its guidance. "Companies need this guidance to do their part," said Grassley.
CMS is accepting comments on the final rule until Feb. 17, 2012.
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